Phase 2
N=17
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Autosomal Dominant Polycystic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00841568 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Jul 2018
Primary outcome: Primary: Total Kidney Volume — 1500.5; 1573.1; 1567.9; 1729.4 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OPC-41061 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Kidney Volume |
1500.5; 1573.1; 1567.9; 1729.4; 1647.7 | — |
| PRIMARY Renal Function Test (eGFR) |
63.0; 64.0; 64.0; 58.5; 59.0 | — |
Summary
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Eligibility Criteria
Inclusion Criteria
- Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
- Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Exclusion Criteria
- Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
- Patients with any of the following complications
- Uncontrolled hypertension
- Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)"
- Patients with any of the following complications or history thereof
- Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto)
- Inability to personally give consent due to a mental disease "
- Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
- Patients with history of massive bleeding or bleeding tendency
- Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
- Pregnant women, lactating women, or women who may become or plan to become pregnant
- Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
- Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Data sourced from ClinicalTrials.gov (NCT00841568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.